Chinese supplier Siyang HolyMed outsourced some of its surgical gowns production to a non-registered, non-qualified facility where sterility could not be assured, sending hospitals into panic mode after Cardinal Health recalled 9 million of the gowns after they learned about the safety issue. According to MassDevice.com, Cardinal Health said in a news release that it has terminated its relationship with the Chinese supplier after learning about the problem in December 2019.
Production Facilities Lacked Sanitation
Cardinal Health apparently already knew that Siyang HolyMed could pose problems because, in spring 2018, Cardinal Health learned that the supplier had outsourced some of its production to a non-registered, non-qualified facility. The company said the facilities in which the gowns were manufactured did not maintain proper environmental conditions. The gowns may have been exposed to contaminants through open windows, failure to provide hand sanitation and operators eating in the production area, officials said.
Cardinal Health warned customers about potential quality issues with the Level 3 gowns and procedure packs that contain them. About 7.7 million were distributed to 2,807 facilities across the country. The gowns were produced by a contract manufacturer in two locations that were neither registered with the FDA nor qualified by Cardinal Health to manufacture surgical gowns.
The company said it is recalling 2.9 million procedure packs manufactured between September 2018 and January 2020 that contain the affected gowns, a subset of the 9 million previously announced. The company also issued an apology to customers and patients for the disruptions to the healthcare system that will affect patient care. These recalls have sent hospitals scrambling and has even caused surgeries to be rescheduled because of the lack of surgical gowns.
If You Have Been Affected
The Food and Drug Administration has said it doesn’t know of anyone who has suffered adverse health issues as a result of the surgical gowns. Cardinal Health has said it is taking a number of actions to deal with the gown shortages including increasing manufacturing and mobilizing employees to work directly with healthcare providers to replace gowns and procedure packs.
If you have been affected as a result of these defectively manufactured products, you may be able to seek compensation from a number of different parties for the injuries, damages and losses you have sustained. An experienced product defect lawyer will be able to advise victims and their families regarding their legal rights and options.